Providing Cleanroom Certification, ASHRAE 110 Testing, Calibration, Decontamination, USP 797 Solutions, Compressed Air Line Testing, Environmental Monitoring and Qualification Services

Environmental Monitoring

Environmental Monitoring – Viable and Non-Viable Testing
Environmental Monitoring is a critical process utilized to assess cleanrooms and other controlled environments within the pharmaceutical and biotechnology industries. It serves as an important pro-active tool for Quality Assurance programs in the manufacture and control of sterile and non-sterile products and support areas.

Micro-Clean Inc. adheres to environmental testing guidelines for static and dynamic testing, according to FS 209E, ISO 14644-1, USP, EU and Sept. 2004 FDA guideline on sterile drug products produced by aseptic processing. This is accomplished by using the most advanced equipments such as BIOTEST RCS, RCS Plus Air Samplers, RODAC plates, BBL swabs and Laser Particle Counters.

Our Environmental Monitoring Specialists not only execute testing but also report your results using thorough yet concise data formats. The samples collected are delivered to Microbiological Environments (http://www.microbioenv.com/), our affiliate in-house (located within our facility) microbiology laboratory/ consulting service for analysis. Together, we create synergy that enables our customers to obtain rapid results to identify any current or potential contamination. Clients also benefit from rapid processing of samples, delivery of reports and convenient access to professional microbiological expertise.

 

A few our recent clients:

Alcan Packaging - Bethlehem, PA
Kos Pharmaceutical, Inc. - Edison, NJ
LTS - Caldwell, NJ
Merck - Rahway, NJ
Micron Technologies - Exton, PA
Shire Laboratories - Rockville, MD
West Pharmaceuticals - Lionville, PA
Wyeth - Marietta, PA

Gown Certified

We provide Environmental Monitoring in the following areas:

Airborne viable testing
An RCS Plus Air Sampler is used to collect the airborne viable micro-organisms (if any) on an RCS strip. The strips are then removed and analyzed by Microbiological Environments.

Surface viable testing
RODAC plates and swabs are used for surface viable sampling. They are placed on different surfaces, such as table benches, cleanroom floors, manufacturing equipment and walls to be tested for potential contamination.

Personnel gown monitoring
RODAC plates are also used to monitor the contamination level of personnel gowns and Personal Protective Equipment (PPEs) before or during manufacturing production.

Non-viable testing
To test for non-viable microorganisms, a MetOne Laser Particle Counter is used to obtain the contamination level of a laboratory or cleanroom.

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